Tests AMT-260 gene therapy in adults with one-sided temporal lobe epilepsy
Tests AMT-260 gene therapy in adults with hard-to-treat temporal lobe epilepsy.
Plain-language title generated from the registry record
Registry title: AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Key facts
- Where
- Austin, Baltimore, Bethesda, Birmingham, Boston, Cleveland, Columbus, Grand Rapids, Hackensack, Jacksonville, Kansas City, Lebanon, Milwaukee, New Brunswick, Palo Alto, Philadelphia, Phoenix, and Pittsburgh, United StatesSee the 18 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06063850, who can take part
Where in United States
- Baylor Scott & White Medical CenterAustin, United StatesTaking people
- Johns Hopkins School of MedicineBaltimore, United StatesTaking people
- Midatlantic Epilepsy and Sleep CenterBethesda, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Ohio State UniversityColumbus, United StatesTaking people
- Corewell HealthGrand Rapids, United StatesTaking people
- Northeast Regional Epilepsy GroupHackensack, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- Kansas University Medical CenterKansas City, United StatesTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Robert Wood Johnson HospitalNew Brunswick, United StatesTaking people
- Stanford UniversityPalo Alto, United StatesNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesTaking people
- Mayo Clinic - ArizonaPhoenix, United StatesTaking people
- Allegheny Health NetworkPittsburgh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UniQure Biopharma B.V.
- Trial code
- NCT06063850
- Record updated
- 24 August 2026
- Original description
The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).Read full original descriptionShow less
A Multi-center, Phase 1/2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered Via Magnetic Resonance Imaging (MRI)-Guided Convection-enhanced Delivery (CED)
The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).
Inclusion: Diagnosis of unilateral refractory MTLE; History of seizures with an average of ≥ 2 documented focal impaired awareness seizures or focal to bilateral tonic-clonic seizures per 30-day period over the 3 month Retrospective Period; On a stable type and dose regimen of up to a maximum of 4 approved Anti Seizure Drugs for at least 1 month prior to the Retrospective Period; Confirmed unilateral hippocampal pathology and concordant unilateral seizure focus; No evidence of focal neurocognitive dysfunction, inconsistent with disease pathology- related MRI and/or (18F)FDG-PET findings; Women of childbearing potential (WOCBP) and fertile male subjects must be willing and able to use highly effective methods of birth control consistently and correctly throughout the study; For WOCBP only: Negative pregnancy test.
Exclusion: Implanted devices that would contraindicate MRI; MRI-compatible devices must be implanted ≥3 months prior to Screening (vagus nerve stimulation devices will be up to discretion of the Investigator); Any other contraindications to general anesthesia, surgery, or intra-operative magnetic resonance imaging (MRI); Previous major disease-unrelated neurosurgical intervention due to intracranial tumor, trauma, or bleeding and/or history of previous intracranial surgery for treatment of epileptic seizures, not including diagnostic stereo-EEG; Status epilepticus within the year prior to Screening; Bilateral or multifocal epilepsy; or inability to confidently lateralize seizure onset; Dementia or other progressive neurological disorders and progressive brain lesions; Medications that could confound clinical (e.g., antipsychotic medication and anti-viral therapy) and laboratory evaluations or could affect a participant's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule; MRI evidence of epileptogenic, extra-temporal lesions, or dual temporal lobe pathology.